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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04969510
Additional trial details provided through ANZCTR are available at the end of this record.
Registration number
NCT04969510
Ethics application status
Date submitted
8/07/2021
Date registered
20/07/2021
Date last updated
19/08/2022
Titles & IDs
Public title
A Clinical Trial of Adjunctive and Monotherapy PRAX-114 in Participants With Major Depressive Disorder
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Scientific title
A Phase 2 Double-blind, Placebo-Controlled, Dose-Ranging Clinical Trial to Evaluate the Efficacy and Safety of PRAX-114 in Adjunctive and Monotherapy Treatment of Participants With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
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Secondary ID [1]
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PRAX-114-214
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder
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Condition category
Condition code
Mental Health
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Depression
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - 10 mg PRAX-114
Treatment: Drugs - 20 mg PRAX-114
Treatment: Drugs - 40 mg PRAX-114
Treatment: Drugs - 60 mg PRAX-114
Treatment: Drugs - Placebo
Experimental: PRAX-114 (10 mg) - 10 mg PRAX-114 once daily
Experimental: PRAX-114 (20 mg) - 20 mg PRAX-114 once daily
Experimental: PRAX-114 (40 mg) - 40 mg PRAX-114 once daily
Experimental: PRAX-114 (60 mg) - 60 mg PRAX-114 once daily
Placebo Comparator: Placebo - Placebo once daily
Treatment: Drugs: 10 mg PRAX-114
Once daily oral treatment
Treatment: Drugs: 20 mg PRAX-114
Once daily oral treatment
Treatment: Drugs: 40 mg PRAX-114
Once daily oral treatment
Treatment: Drugs: 60 mg PRAX-114
Once daily oral treatment
Treatment: Drugs: Placebo
Once daily oral treatment
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from baseline in HAM-D17 total score at Day 15
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Assessment method [1]
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The HAM-D17 is a depression rating scale consisting of 17 items; 9 items are scored on a 5-point scale (ranging from 0 to 4), and 8 items are scored on a 3-point scale (ranging from 0 to 2). The total score of the 17 items ranges from 0 to 52 with higher scores indicating greater depression. Therefore, a decrease in the total score or on individual item scores indicates improvement.
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Timepoint [1]
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15 days
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Secondary outcome [1]
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Change from baseline in HAM-D17 total score at Day 29
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Assessment method [1]
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The HAM-D17 is a depression rating scale consisting of 17 items; 9 items are scored on a 5-point scale (ranging from 0 to 4), and 8 items are scored on a 3-point scale (ranging from 0 to 2). The total score of the 17 items ranges from 0 to 52 with higher scores indicating greater depression. Therefore, a decrease in the total score or on individual item scores indicates improvement.
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Timepoint [1]
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29 days
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Secondary outcome [2]
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Change from baseline in HAM-D17 total score at all other time points
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Assessment method [2]
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The HAM-D17 is a depression rating scale consisting of 17 items; 9 items are scored on a 5-point scale (ranging from 0 to 4), and 8 items are scored on a 3-point scale (ranging from 0 to 2). The total score of the 17 items ranges from 0 to 52 with higher scores indicating greater depression. Therefore, a decrease in the total score or on individual item scores indicates improvement.
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Timepoint [2]
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4 days, 8 days, 22 days, 36 days, and 43 days
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Secondary outcome [3]
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Change from baseline in Clinical Global Impression-Severity (CGI-S) score at Day 15 and all other time points
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Assessment method [3]
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The CGI-S assesses the clinician's impression of the participant's current depression symptoms. The clinician should use his/her total clinical experience with this patient population and rate the current severity of the participant's mental illness on a 7-point scale from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients).
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Timepoint [3]
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4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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Secondary outcome [4]
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Clinical Global Impression-Improvement (CGI-I) score at Day 15 and all other time points
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Assessment method [4]
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The CGI-I assesses the participant's improvement (or worsening). The clinician is required to assess the participant's condition relative to Baseline (Day 1) on a 7-point scale from 1 (Very much improved) to 7 (Very much worse).
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Timepoint [4]
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4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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Secondary outcome [5]
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HAM-D17 response (reduction from baseline score of =50%) at Day 15, Day 29, and all other time points
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Assessment method [5]
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The HAM-D17 is a depression rating scale consisting of 17 items; 9 items are scored on a 5-point scale (ranging from 0 to 4), and 8 items are scored on a 3-point scale (ranging from 0 to 2). The total score of the 17 items ranges from 0 to 52 with higher scores indicating greater depression. Therefore, a decrease in the total score or on individual item scores indicates improvement.
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Timepoint [5]
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4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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Secondary outcome [6]
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HAM-D17 remission (total score of =7) at Day 15, Day 29, and all other time points
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Assessment method [6]
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The HAM-D17 is a depression rating scale consisting of 17 items; 9 items are scored on a 5-point scale (ranging from 0 to 4), and 8 items are scored on a 3-point scale (ranging from 0 to 2). The total score of the 17 items ranges from 0 to 52 with higher scores indicating greater depression. Therefore, a decrease in the total score or on individual item scores indicates improvement.
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Timepoint [6]
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4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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Secondary outcome [7]
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Change from baseline in the Symptoms of Depression Questionnaire (SDQ) total and sub-scale scores at Day 15 and all other time points
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Assessment method [7]
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The SDQ is a 44-item, self-report scale assessing the severity of symptoms across several subtypes of depression. Items are scored on a 7-point scale (ranging from 1 to 6). The SDQ total score is the sum of all 44 item scores and ranges from 44 to 264 with higher scores indicating worse symptoms.
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Timepoint [7]
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4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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Secondary outcome [8]
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Patient Global Impression-Improvement (PGI-I) score at Day 15 and all other time points
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Assessment method [8]
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The PGI-I scale is a global self-assessment used to rate the response of a participant's condition to therapy or intervention. It consists of 1 question that asks the participant to rate their current condition compared to how it was prior to beginning treatment on a scale of 1 (very much better) to 7 (very much worse).
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Timepoint [8]
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4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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Secondary outcome [9]
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Change from baseline in the Work and Social Adjustment Scale (WSAS) at Day 15 and all other time points
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Assessment method [9]
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The WSAS assesses the degree to which mental health problems interfere with day-to-day functioning in 5 domains: work, social leisure activities, private leisure activities, home- management, and personal relationships. The WSAS total score is the sum of the 5 item scores and ranges from 0 to 40, with higher scores indicating poorer adjustment.
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Timepoint [9]
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4 days, 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days
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Eligibility
Key inclusion criteria
1. Recurrent MDD diagnosis with a current episode duration of at least 12 weeks and no
more than 24 months.
2. HAM-D17 total score of =20 at Screening and Baseline
3. Body mass index (BMI) between 18 and 38 kg/m2 (inclusive).
4. Adjunctive treatment participants only: Inadequate response to treatment in the
current MDD episode, defined as <50% reduction in depression severity in response to
at least 1 and no more than 2 antidepressant trials at an adequate dose and duration
in the current MDE as specified in the ATRQ.
5. Adjunctive treatment participants only: Stable regimen of antidepressant treatment for
at least 8 weeks prior to Baseline, with no clinically meaningful change (defined as
no increase in dose and no decrease in dose =25% for tolerability) during that period.
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Minimum age
18
Years
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Maximum age
65
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Lifetime history of seizures, including febrile seizures.
2. Neurodegenerative disorder (eg, Alzheimer's disease, Parkinson's disease, multiple
sclerosis, or Huntington's disease).
3. Lifetime history of bipolar disorder, a psychotic disorder (eg, schizophrenia or
schizoaffective disorder), or obsessive compulsive disorder or a history of a
psychotic mood episode in last 2 years.
4. Any current psychiatric disorder (other than MDD).
5. Lifetime history of treatment resistant depression.
6. Received electroconvulsive therapy (ECT) or vagus nerve stimulation (VNS) within the
last year or transcranial magnetic stimulation (TMS) within the last 6 months prior to
Screening.
7. Daily consumption of more than 2 standard alcohol-containing beverages for males or
more than 1 standard alcohol-containing beverages for females.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/06/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
2/08/2022
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Sample size
Target
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Accrual to date
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Final
110
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Praxis Research Site - Noble Park
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Recruitment postcode(s) [1]
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3174 - Noble Park
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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United States of America
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State/province [3]
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Georgia
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Country [4]
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United States of America
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State/province [4]
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Maryland
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United States of America
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State/province [5]
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Massachusetts
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Country [6]
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United States of America
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State/province [6]
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Missouri
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Country [7]
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United States of America
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State/province [7]
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Nevada
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United States of America
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State/province [8]
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New York
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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State/province [13]
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Virginia
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Country [14]
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United States of America
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State/province [14]
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Washington
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Praxis Precision Medicines
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a randomized, double-blind, placebo-controlled clinical trial to evaluate the
efficacy and safety of 10, 20, 40 and 60 mg oral PRAX-114 compared to placebo in the
treatment of adults with MDD. The study will enroll participants on adjunctive treatment who
had an inadequate response to their current antidepressant treatment and participants not
currently being treated with pharmacotherapy for MDD. A sub-study to investigate the
pharmacokinetics (PK) of PRAX-114 and metabolites when dosed in the evening in participants
with MDD will be conducted in a subset of participants at selected research sites with serial
PK sampling capabilities.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04969510
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Executive Director Clinical Development
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Address
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Praxis Precision Mediciines
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Phone
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04969510
Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
QLD,VIC
Funding & Sponsors
Primary sponsor
Commercial sector/Industry
Primary sponsor name
Praxis Precision Medicines Australia, Pty Ltd
Primary sponsor address
Tower Two Collins Square, Level 36
727 Collins St, Docklands, Vic, 3008
Primary sponsor country
Australia
Ethics approval
Ethics application status
Approved
Public notes
Contacts
Principal investigator
Title
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Name
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